Lucea LED®
LCA50 – KIT Conversion LCA50 SF Vers DF
11manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Dongguan Miqiang Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Shenzhen Yiguangnian Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 13 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Maquet Gmbh, Germany |
|---|---|
| FDA product code | NTN |
| Device type | Led Light Source |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K113679 |
| Record published | 2016-09-15 |
| Record revised | 2024-12-11 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-10-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARD568604954 | In distribution | |
| ARD568604955 | In distribution | |
| ARDLCA506006A | Withdrawn | |
| ARDLCA506000A | Withdrawn | |
| ARDLCA506001A | Withdrawn | |
| ARDLCA109008A | Withdrawn | |
| ARDLCA506009A | Withdrawn | |
| ARDLCA209016A | Withdrawn | |
| ARDLCA506008A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Led Light Source | Schölly Fiberoptic GmbH | 12 |
| Endolight | Richard Wolf Gmbh | 7 |
| ILO | ILO Electronic Gmbh | 7 |
| BR Surgical, LLC | BR Surgical LLC | 7 |
| Led Light Source | Karl Storz GmbH & Co. KG | 6 |
| Everlux Light Source | Ecleris SRL | 5 |
| eLUMA | ConMed Corporation | 5 |
| Led Light Source | Maquet Gmbh | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Comeg Medical | Sopro | 4 |
| Led Light Source | Richard Wolf Gmbh | 4 |
| Comeg Medical Technologies | Sopro | 3 |
Showing 12 of 42. All products under Led Light Source
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Getinge Usa Sales Inc | 510(k) number | 2023-11-08 | Class II | Equipment maintenance | A potential for a light system to fall in the operating room. | 236793 units in total |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.